Kornimate/medical-research-clean huggingface dataset:
impact of the therapeutic education program "living with a chronic inflammatory disease under biotherapy" on patient compliance and quality of life

Conditions: Chronic Inflammatory Disease

Summary: patient therapeutic education programs have been shown to be effective in many specialties, allowing "improving biological and psychological parameters, allowing patients to improve their health knowledge, therapeutic adherence and sense of personal effectiveness." several studies have shown that patient knowledge, adherence and satisfaction are better after attending a therapeutic education program. this multidisciplinary program is presented and offered to all patients with chronic disease treated by subcutaneous biotherapy, followed by dermatologists, rheumatologists and gastroenterologists of the lorient hospital. the study aims to demonstrate the benefit of the patient therapeutic education program at ghbs lorient "living with a chronic inflammatory disease under biotherapy" on treatment adherence, as well as the positive impact on quality of life.

all patients followed up as part of their chronic disease and treated with subcutaneous biotherapy in the dermatology, rheumatology, hepatotherapygastroenterology, will be offered participation in the therapeutic education program by ghbs specialists. whether they agree to participate or not, doctors will offer them participation in the impebio study. patients treated with subcutaneous biotherapy who do not wish to participate in the program will be included in the control group. patients treated with subcutaneous biotherapy who wish to participate in this program will be included in the intervention group. the therapeutic education program will begin within 3 months of inclusion. if the patient does not object, the morisky scale and the sf 12 questionnaire will be given to him. it may be assisted with filling if necessary by a clinical researcher. patients will first complete the morisky test, and the quality of life questionnaire sf 12 at inclusion in the impebio study (j0), then to m6 (6 months), m12 (12 months) and m18 (18 months). these questionnaires will then be retrieved, anonymized and sent to the investigation department. the analysis of questionnaires will not lead to changes in patient management. estimated time to complete the questionnaires is 10 minutes.

Eligibility criteria:
inclusion criteria: * all major patients followed up on ghbs for chronic inflammatory disease treated with s/c biotherapy. * patients not opposed to their participation in the research. * less than 3 months between inclusion and start of therapeutic education program. exclusion criteria: * subcutaneous injection by another person. * patients with cognitive impairment. * persons of legal age who are the subject of a legal protection (safeguarding of justice, curatorship, guardianship), persons deprived of liberty. * pregnant women. * persons not covered by social security.

Keywords: biotherapy therapeutic education program
a study of volociximab in combination with gemcitabine in metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.


Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or older. * histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. * may have received prior immunotherapy (including monoclonal antibodies) or vaccine therapies. * measurable disease, according to recist criteria. * negative pregnancy test (women of childbearing potential only). * pretreatment laboratory levels that meet specific criteria. exclusion criteria: * prior treatment with volociximab (m200) or inhibitors of α5β1 integrin (antibodies or small molecules) or gemcitabine and other chemotherapeutic regimens. * known hypersensitivity to murine proteins or chimeric antibodies or other components of the product. * use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer). * monoclonal antibody therapy within 4 weeks of the first dose of volociximab. * central nervous system (cns) tumor or metastasis. * history of bleeding disorders within the past year. * medical conditions that may be exacerbated by bleeding.

Keywords: antibody pancreas carcinoma cancer pancreatic
pain management after shoulder arthroplasty

Conditions: Caffeine; Pain, Joint

Summary: pain control is a critical after many surgical procedures. it is well known that orthopaedic surgeries are among the most painful procedures, with total joint arthroplasty being a clear example of this situation. current trends in pain management are morphing and multimodal opioid sparing protocols are now being evaluated and implemented, with results showing a decrease in the amount of opioids being prescribed. despite all efforts, most patients experience pain and, in order to control it, multiple medications have been tried with variable results. the most commonly prescribed medications are opioids, but side effects associated with their use as well as their addictive potential are making them a less desirable option for patients. currently there is a trend towards diminishing opioids consumption and prescribing alternative pain control regimens.caffeine is a well known molecule that when associated with non-steroidal anti-inflammatory drugs (nsaids) potentiates their analgesic effect and decreases the amount of doses required to control pain. little is known about the effect of caffeine over pain relief in patients undergoing total joint arthroplasty, but preliminary results in other fields make us believe it could have a potential benefit for patients undergoing total joint arthroplasty.


Eligibility criteria:
inclusion criteria: * adult patients who undergo primary total shoulder arthroplasty or reverse total shoulder arthroplasty * patient willing and able to complete postoperative surveys * post-menopausal women and men over the age of 55 exclusion criteria: * patients reporting caffeine consumption in excess of 300mg daily * patient has known history of opioid addiction, has taken opioids preoperatively, or other forms of substance abuse. * patient has history of cardiac diseases that might be aggravated by the use of caffeine, as diagnosed by a cardiologist or demonstrated by an abnormal ekg. * patient has a known allergy to aspirin or caffeine. * patient has history of cancer, neuropathic pain, or nerve degenerative disease that would affect patient reported outcomes including pain. * patient has history of anxiety disorder * patients with known sleep disturbances that would otherwise be affected by caffeine * patients undergoing revision surgery * patients who require alternate dvt prophylaxis other than asa. * patients undergoing inpatient arthroplasty * workman's comp patient or patient has current litigation pending
an observational study for gastric cancer in asymptomatic carriers of high risk helicobacter pylori

Conditions: Gastric (Stomach) Cancer; Helicobacter Infection

Summary: this study is intended to be a prospective observational cohort study. the incidence of gastric cancer and progression of gastric precancerous lesions will be compared between groups through prospective follow-up of a population of asymptomatic carriers harboring high-risk hp snp subtypes and non-high-risk subtypes.

primary study objective: to assess the difference in the incidence of gastric cancer between asymptomatic carriers of high-risk snp subtypes of h. pylori and the non-high-risk population during the follow-up period. secondary research objectives: 1. to observe and compare the cumulative incidence and progression of gastric precancerous lesions (e.g., atrophic gastritis, intestinal metaplasia, etc.) in each population group during the follow-up period.2. to explore the interaction of high-risk snps on the risk of gastric cancer in the context of different age, gender or other risk factors (e.g. diet, smoking, alcohol abuse, family history, etc.).

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, gender is not limited; 2. no previous history of gastric cancer (no radical surgery or radiotherapy treatment for gastric cancer); 3. able and willing to provide informed consent and willing to accept baseline and follow-up examinations; 4. able to cooperate in completing hp testing (breath test, gastroscopic biopsy or other standard testing methods) and hp snp typing by stool testing; 5. no obvious gastric symptoms at the time of initial screening, no progressive gastric cancer or serious gastric diseases (e.g., perforated acute ulcers, upper gastrointestinal hemorrhage, etc.) detected, and no need for urgent surgery (not planned within 3 months) or other therapeutic interventions for the time being. exclusion criteria: 1. diagnosed gastric cancer or other malignant tumors of the digestive tract; 2. comorbid serious underlying diseases (e.g., severe cardiopulmonary insufficiency, liver and renal failure, etc.) that are expected to have a short survival time or are not suitable for long-term follow-up; 3. inability to complete or refusal to undergo hp testing, snp gene testing or follow-up; 4. presence of severe mental illness or incapacity for civil behavior that prevents completion of the study; 5. pregnant or breastfeeding women who are temporarily excluded; 6. other conditions that the investigator considers unsuitable for participation in this study.
niraparib as maintenance treatment in platinum responsive ovarian cancer patients: a real life study

Conditions: Ovarian Cancer

Summary: this is an observational phase iv study evaluating niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting.

this is an observational phase iv study evaluating niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting. will be enrolled all patients who have been part of the italian compassionate use program (cup) prior to participating in this study. once the cup will be closed the trial will continue with th prospective collection of data of patients treated with niraparib according to the label for 2 years.

Eligibility criteria:
inclusion criteria: * patients that received niraparib as monotherapy for the maintenance treatment of platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after response (complete or partial) to platinum-based chemotherapy as part of the cup, regardless of whether the patient is receiving niraparib at the time of enrolment; * patients with high grade serous ovarian cancer treated with niraparib according to the label will be included; * patients able to understand the study procedures and that agree to participate in the study by providing written informed consent exclusion criteria: no exclusion criteria
distress tolerance for benzodiazepine discontinuation

Conditions: Substance Use Disorders

Summary: the proposed study is a clinical trial, designed to pilot test a distress tolerance-benzodiazepine discontinuation (dt-bd) intervention for patients on opioid agonist therapy (oat) who currently use benzodiazepines versus a relaxation therapy (rt) control condition. the dt-bd intervention is an adjunctive psychosocial intervention in people seeking to discontinue (bzd) use.

this study pilot tests a 13-week distress tolerance-based psychosocial intervention paired with a benzodiazepine taper comparing it to a relaxation therapy control condition with the aim of assisting individuals receiving oat discontinue benzodiazepine use. all participants will receive the same benzodiazepine (bzd) discontinuation protocol. the distress tolerance-benzodiazepine discontinuation (dt-bd) intervention consists of 13 weeks with 5 weekly therapy sessions prior to a 9-week bzd taper. some participants may be prescribed non-benzodiazepine medications to treat the underlying conditions for which they were using bzds \[e.g. selective serotonin reuptake inhibitors (ssri) for anxiety or hypnotics for insomnia\]. data collection will occur at baseline, then weekly for 13 weeks.

Eligibility criteria:
inclusion criteria: * age 18 or older * receiving oat (methadone or buprenorphine) for at least 2 weeks * regular bzd use defined by bzd use 3 or more times per week in past month by self-report and positive urine screen at time of recruitment * provides permission to contact current bzd prescriber if being prescribed bzds * speaks english * wants to discontinue bzd use * capacity to provide informed consent exclusion criteria: * pregnant, confirmed by urine pregnancy test * cognitive impairment, as indicated by montreal cognitive assessment (moca): must score at least 26 on the moca with a one-point adjustment for individuals with formal education of 12 years or fewer * any past month illicit opioid determined by self-report or urine drug test; illicit defined as non-medical use * receiving ongoing psychosocial treatment for bzd use disorder * uncontrolled seizure disorder (i.e. seizure in prior 90 days), or past bzd withdrawal seizure * current suicidality or homicidality * current psychotic symptoms
evaluation of target organs impairment on patients suffering from high blood pressure

Conditions: Blood Pressure

Summary: evaluation of target organs impairment on patients suffering from high blood pressure without known cardio vascular or renal disease, stratified on blood pressure control.


Eligibility criteria:
inclusion criteria: * adults with hypertension (treated or not), without known cardiovascular or renal disease.

Keywords: target organs impairment high blood pressure evaluation of target organs impairment on patients suffering from high blood pressure without known cardiovascular or renal disease
gabapentin dosages for postoperative analgesia following open thoracotomy

Conditions: Thoracotomy; Pain, Postoperative

Summary: gabapentin is a nerve medication that treats pain. the specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night. our hypothesis is that higher doses of gabapentin will correlate with decreased pain at the incision and chest tube sites and decreased opioid consumption.

the purpose of this study is to determine the effectiveness of various dosages of gabapentin, as part of an eras protocol, for postoperative analgesic control after open thoracotomy and additionally determine if there is a correlation of the dosage of gabapentin with pulmonary complication and impaired cognition postoperatively. given the widespread use of gabapentin and the huge variability in dosing, our study aims to simplify eras protocols for thoracotomy by figuring out the optimal dosing of gabapentin and whether its use overall decreases postoperative opioid consumption and complications. the specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night.

Eligibility criteria:
inclusion criteria: * pt undergoing open thoracotomy at indiana university hospital * asa 1,2,3 or 4 * age 18 or older, male or female exclusion criteria: * history of substance abuse in the past 6 months which would include heroin, marijuana or any other illegal street drugs * patient on home dose of gabapentin or pregabalin * patient staying intubated after surgery * patient above 70yo * patient (home dose) taking more than 30mg po morphine equivalent (pme) per day * known allergy or other contraindications to the study medications, which include gabapentin * patient unable to receive post-op epidural * bmi above 40 * creatinine clearance less than 30

Keywords: acute pain neuropathic pain
duloxetine versus paroxetine for major depression

Conditions: Major Depressive Disorder

Summary: to determine if duloxetine works just as well as paroxetine in the treatment of major depressive disorder.


Eligibility criteria:
inclusion criteria: * you are male or female at least 18 years of age with nonpsychotic major depression. females of child-bearing potential must test negative on a pregnancy test at visit 1. exclusion criteria: * you have a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality. * you have a history of hepatic dysfunction, current jaundice, or positive hepatitis b surface antigen or positive hepatitis c surface antibody regardless of alt. * you have an alt greater than or equal to 2 times the upper limit of normal. * you have abnormal thyroid-stimulating hormone concentrations.
effect of the addition of dexmedetomidine to bupivacaine during supraclavicular brachial plexus blockade

Conditions: Sequelae of Fracture of Forearm and Upper Arm

Summary: the aim of this study was effect of the addition of dexmedetomidine to bupivacaine during supraclavicular brachial plexus blockade for forearm surgery, by low doses bupivacaine providing prolonged analgesia after surgery.

anaesthesia for surgeries to the upper extremity commonly is provided using brachial plexus anaesthesia.various local anaesthetic mixtures can be used to prolong local anaesthesia duration and epinephrine , opioids and dexmedetomidine are frequently used for this purpose. this study was conducted to compare the effects of adding dexmedetomidine to local anaesthetics in the supraclavicular brachial plexus block by using nerve stimulators and ultrasonography guided. dexmedetomidine has also been found the prolong the duration of bupivacaine infraclavicular brachial plexus block.

Eligibility criteria:
inclusion criteria: * 18-65 age * unwanted general anaesthesia * asa 1-2 * single forearm, arm surgery exclusion criteria: * major psychiatric problems * major neurologic deficits * coagulopathy * drug allergies * chronic analgesic used

Keywords: supraclavicular block
study of acetyllevocarnitine hydrochloride tablets in chinese patients with paresthesias caused by dpn

Conditions: Diabetic Peripheral Neuropathy (DPN); Paresthesia

Summary: the purpose of this study is to assess the efficacy of acetyllevocarnitine hydrochloride tablets compared with placebo after 24 weeks, in chinese patients with paresthesia caused by diabetic peripheral neuropathy (dpn).

this 24-week, multicentre, randomised, double-blind, placebo-controlled phase iii study is to assess the efficacy and safety of acetyllevocarnitine hydrochloride tablets in chinese patients with paresthesia caused by dpn.the trial included a 2-week screening period, a 1-week placebo run-in period, a 24-week randomized treatment period, and a 2-week follow-up period.

Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 70 years, male and female patients; * type 1 or 2 diabetes mellitus on hypoglycemic therapy for 3 months or more, and clinical diagnosis of dpn; * hba1c \< 9.0%; * toronto clinical neuropathy score ≥ 6 at screening and baseline. exclusion criteria: * peripheral neuropathy caused by other diseases; * history of acute complications of diabetes within the past 6 months, such as diabetic ketoacidosis, diabetic hyperosmolar hyperglycemia syndrome or lactic acidosis, etc.; * severe peripheral arterial disease; severe cardiopulmonary disease; or have a history of myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months before enrollment; or uncontrolled asthma or shortness of breath 2 months before enrollment; world health organization (who) cardiac function class iii-iv; systolic blood pressure \>160 mmhg or diastolic blood pressure \>90 mmhg at screening; * any infection at the screening visit that is not suitable for study participation; * aspartate transaminase (ast) or alanine transaminase (alt) or total bilirubin or creatinine \> 2 times upper limit of normal (uln); * known allergy to l-carnitine ingredients; * severe systemic or psychiatric illness, history of epilepsy; * history of malignancy or antitumor therapy; * severe bleeding disorder; * clinically significant abnormalities in thyroid function tests; * triglyceride \>5.6 mmol/l; * change of 2 points or more in the same item in mtcns; * nursing or pregnant women.
car-t cd19 for acute myelogenous leukemia with t 8:21 and cd19 expression

Conditions: Acute Myeloid Leukemia

Summary: chimeric antigen receptor (car-t) engineered t cells against the cd19 protein have been shown to be effective against acute lymphoma and lymphocytic leukemia and are approved by the us (fda), european (ema) and health basel. however, little information exists on using cd19car for treatment of recurrent or irresponsible to previous treatment acute myeloid leukemia. the proposed study will include patients with recurrent disease or those with disease irresponsible to common treatments and they will be treated with car-t cd19.


Eligibility criteria:
inclusion criteria: * patients with recurrent acute myeloid leukemia (aml) including those after bone marrow transplantation or not responding to previous therapy, who have exhausted other approved relevant therapies such as chemotherapy protocols that are ineffective and with high toxicity, or flt3 inhibitors in patients with flt3 . exclusion criteria: * heart disease including severe heart failure (nyha iii-iv), recent mi or cabg surgery (in previous six months), severe ventricular rhythm abnormalities, non ischemic heart disease, lvef less than 45% * active involvement of cns * active infection * pregnancy or lactation * graft versus host disease iii-iv grade - stroke or seizure in the last six months before treatment * a positive result for the hiv infection (serum) * active hepatitis infection * life-threatening allergies to cyclophosphamide or fludarabine * no informed consent signed by candidate * candidate enrolled in other study

Keywords: chimeric antigen receptors; mixed phenotype acute leukemia; t cells.